510(k) · Cleared
Recalled · 2006Lithostar Modularis with Shockwave System Cplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MMZ Table, Cystometric, Electric
Cleared on Nov 25, 2003 as substantially equivalent to P870018 (Siemens Corp., 1988) after a 40-day review. Its family tree reaches back 1 generation to 1988. It has been recalled once.
- Decided
- Nov 25, 2003
- Review
- 40 days
- Class
- Class II
- Product code
- MMZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to P870018 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backP870018 LithostarSiemens Corp. · 1988
- This deviceK033335 Lithostar Modularis with Shockwave System CplusSiemens Medical Solutions USA, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P870018 | Lithostar | Siemens Corp. | 1988 | — |
| 0 (this device) | K033335 | Lithostar Modularis with Shockwave System Cplus | Siemens Medical Solutions USA, Inc. | 2003 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P870018 | LithostarSummary page 1…LITHOSTAR MODULARIS A. Legally marketed device to which the device is substantially equivalent The predicate device is the Siemens LITHOSTAR MODULARIS, P870018, Supplement 21. B. Description of device Siemens LITHOSTAR MODULARIS with Shockwave System Cplus is a… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 1, 2006 | Not classified | Z-0168-2007 | Other | Potential pinch point with the patient table |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate P870018.
How does its category compare?
All MMZ devicesMMZ Table, Cystometric, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMZ
FDA has decided no MMZ device since 2007.
Median 510(k) review, days · MMZ
Too few MMZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MMZ
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMZ
2in 2025
MAUDE reports naming product code MMZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 3 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
LITHOSTAR Modularis with Shockwave System Cplus is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033335: Lithostar Modularis with Shockwave System Cplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033335
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026